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    Clinical Trial Results:
    A 1-Year, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients with Heterozygous Familial Hypercholesterolemia (REALIZE)

    Summary
    EudraCT number
    		 2011-004525-27
    Trial protocol
    		 GB   DE   NL   ES   CZ  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    05 Apr 2016
    First version publication date
    19 Jul 2015
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MK-0859-020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01524289
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    12 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Feb 2014
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    1. Evaluate the efficacy of adding anacetrapib 100 mg for 52 weeks relative to placebo on plasma concentrations of low-density lipoprotein-cholesterol (LDL-C). 2. Evaluate the safety and tolerability of 52 weeks of treatment with anacetrapib 100 mg.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 Participants were treated with an optimal dose of statin, (i.e. doses of statin >= simvastatin 40 mg, atorvastatin 20 mg, rosuvastatin 5 mg, pitavastatin 4 mg, lovastatin 80 mg or pravastatin 80 mg), ± other lipid-modifying medication(s) for at least 6 weeks prior to Visit 1.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Feb 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 102
    Country: Number of subjects enrolled
    Norway: 29
    Country: Number of subjects enrolled
    Spain: 48
    Country: Number of subjects enrolled
    United Kingdom: 25
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Canada: 50
    Country: Number of subjects enrolled
    Russian Federation: 8
    Country: Number of subjects enrolled
    United States: 9
    Worldwide total number of subjects
    306
    EEA total number of subjects
    239
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    239
    From 65 to 84 years
    67
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were to complete a 2-week placebo run-in, a 52-week treament period and a 12-week reversal period (safety follow-up).

    Pre-assignment
    Screening details
    		 The study enrolled participants 18 to 80 years of age, with a genotype-confirmed or clinical diagnosis of heterozygous familial hypercholesterolemia (HeFH) and had been treated with an optimal dose of statin for at least 6 weeks. Other inclusion and exclusion criteria applied.

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Anacetrapib 100 mg
    Arm description
    		 One tablet of anacetrapib 100 mg once daily with a meal for 52 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anacetrapib
    Investigational medicinal product code
    Other name
    MK-0859
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 100 mg tablet once daily for 52 weeks

    Arm title
    		 Placebo
    Arm description
    		 One matching placebo tablet once daily with a meal for 52 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to match anacetrapib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    one placebo tablet once daily for 52 weeks

    Number of subjects in period 1
    		Anacetrapib 100 mg Placebo
    Started
    204
    102
    Treated
    203
    102
    Completed
    174
    88
    Not completed
    30
    14
         Physician decision
    1
    -
         Consent withdrawn by subject
    11
    7
         Adverse event, non-fatal
    12
    5
         did not take study medication
    1
    -
         Lost to follow-up
    -
    1
         Protocol deviation
    5
    1
    Period 2
    Period 2 title
    Reversal Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Anacetrapib 100 mg - Reversal
    Arm description
    		 Participants who completed treatment period and participants who were discontinued during treatment period (non-completers) who were administered anacetrapib in treatment period and entered reversal period. No study drug was administered during Reversal Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anacetrapib
    Investigational medicinal product code
    Other name
    MK-0859
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 100 mg tablet once daily for 52 weeks

    Arm title
    		 Placebo - Reversal
    Arm description
    		 Participants who completed treatment period and participants who were discontinued during treatment period (non-completers) who were administered placebo in treatment period and entered reversal period. No study drug was administered during Reversal Period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to match anacetrapib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo tablet once daily for 52 weeks

    Number of subjects in period 2
    		Anacetrapib 100 mg - Reversal Placebo - Reversal
    Started
    174
    88
    Completed
    195
    95
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -
    Joined
    22
    7
         Non-completers from treatment period
    22
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Anacetrapib 100 mg
    Reporting group description
    		 One tablet of anacetrapib 100 mg once daily with a meal for 52 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 One matching placebo tablet once daily with a meal for 52 weeks

    Reporting group values
    		 Anacetrapib 100 mg Placebo Total
    Number of subjects
    		 204 102 306
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55 ( 11.8 ) 55.7 ( 11.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 84 52 136
        Male
    		 120 50 170

    End points

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    End points reporting groups
    Reporting group title
    Anacetrapib 100 mg
    Reporting group description
    		 One tablet of anacetrapib 100 mg once daily with a meal for 52 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 One matching placebo tablet once daily with a meal for 52 weeks
    Reporting group title
    Anacetrapib 100 mg - Reversal
    Reporting group description
    		 Participants who completed treatment period and participants who were discontinued during treatment period (non-completers) who were administered anacetrapib in treatment period and entered reversal period. No study drug was administered during Reversal Period.

    Reporting group title
    Placebo - Reversal
    Reporting group description
    		 Participants who completed treatment period and participants who were discontinued during treatment period (non-completers) who were administered placebo in treatment period and entered reversal period. No study drug was administered during Reversal Period.

    Subject analysis set title
    Anacetrapib 100 mg- Efficacy Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received at least 1 dose of study treatment had baseline data and at least 1 post-dose observation for the analysis endpoint.

    Subject analysis set title
    Placebo - Efficacy Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received at least 1 dose of study treatment had baseline data and at least 1 post-dose observation for the analysis endpoint.

    Subject analysis set title
    Anacetrapib 100 mg - Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All particpants who receive at least 1 dose of study drug.

    Subject analysis set title
    Placebo - Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants who receive at least 1 dose of study drug.

    Primary: Percent Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C)

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    End point title
    		 Percent Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C)
    End point description
    LDL-C levels measured at baseline and after 52 weeks of treatment using beta quantification method.
    End point type
    Primary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    165 [1]
    85 [2]
    Units: Percentage change
        least squares mean (confidence interval 95%)
    -36 (-39.5 to -32.5)
    3.7 (-1.2 to 8.6)
    Notes
    [1] - met criteria for inclusion in analysis of endpoint
    [2] - met criteria for inclusion in analysis of endpoint
    Statistical analysis title
    		 Comparison of Percent Change from Baseline
    Statistical analysis description
    Between group comparison of percent change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who receive at least 1 dose of study treatment and have baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Mean
    Point estimate
    -39.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45.7
         upper limit
    		 -33.7

    Primary: Percentage of Participants With Any Adverse Event (AE)-Treatment Period

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    End point title
    		 Percentage of Participants With Any Adverse Event (AE)-Treatment Period
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    203
    102
    Units: Percentage of Participants
        number (not applicable)
    76.4
    78.4
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.5
         upper limit
    		 8.4

    Primary: Percentage of Participants With Any Drug-related AE - Treatment Period

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    End point title
    		 Percentage of Participants With Any Drug-related AE - Treatment Period
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. AEs reported by the investigator as definitely, probably or possibly related to study drug were considered drug-related.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    203
    102
    Units: Percentage of Participants
        number (not applicable)
    18.2
    13.7
    Statistical analysis title
    		 Difference in Percentage Between Groups
    Statistical analysis description
    Difference in percentages between groups compared using Miettinen and Nurminen method
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 12.6

    Primary: Percentage of Participants With Any Serious Adverse Event (SAE) - Treatment Period

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    End point title
    		 Percentage of Participants With Any Serious Adverse Event (SAE) - Treatment Period
    End point description
    An AE or suspected adverse reaction is considered an SAE if it results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    203
    102
    Units: Percentage of Participants
        number (not applicable)
    8.9
    9.8
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.9
         upper limit
    		 5.6

    Primary: Percentage of Participants With Any Drug-related SAE - Treatment Period

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    End point title
    		 Percentage of Participants With Any Drug-related SAE - Treatment Period
    End point description
    An AE or suspected adverse reaction is considered an SAE if it results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. SAEs reported by the investigator as definitely, probably or possibly related to study were considered to be drug-related.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    203
    102
    Units: Percentage of Participants
        number (not applicable)
    0
    0
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Placebo - Safety Population v Anacetrapib 100 mg - Safety Population
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 1.9

    Primary: Percentage of Participants With Any AE Leading to Discontinuation of Treatment

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    End point title
    		 Percentage of Participants With Any AE Leading to Discontinuation of Treatment
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. Adverse Events that were reported as the cause for discontinuation of the study drug were recorded.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    203
    102
    Units: Percentage of Participants
        number (not applicable)
    5.9
    4.9
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.5
         upper limit
    		 6.1

    Primary: Percentage of Participants With Elevations in Systolic Blood Pressure (SBP) >= 10 mm Hg

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    End point title
    		 Percentage of Participants With Elevations in Systolic Blood Pressure (SBP) >= 10 mm Hg
    End point description
    Participants had SBP assessed at baseline and throughout the 52 week treatment period. Participants who had a SBP reading that was >= 10 mm Hg higher than their baseline SBP for any assessment performed during the treatment period were recorded.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    202
    101
    Units: Percentage of Participants
        number (not applicable)
    45
    53.5
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Placebo - Safety Population v Anacetrapib 100 mg - Safety Population
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.168
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -8.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.1
         upper limit
    		 3.5

    Primary: Percentage of Participants With Elevations in SBP >= 15 mm Hg

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    End point title
    		 Percentage of Participants With Elevations in SBP >= 15 mm Hg
    End point description
    Participants had SBP assessed at baseline and throughout the 52 week treatment period. Participants who had a SBP reading that was >= 15 mm Hg higher than their baseline SBP for any assessment performed during the treatment period were recorded.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    202
    101
    Units: Percentage of Participants
        number (not applicable)
    26.2
    33.7
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.179
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -7.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.7
         upper limit
    		 3.3

    Primary: Percentage of Participants With Elevations in Diastolic Blood Pressure (DBP) >= 10 mm Hg

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    End point title
    		 Percentage of Participants With Elevations in Diastolic Blood Pressure (DBP) >= 10 mm Hg
    End point description
    Participants had DBP assessed at baseline and throughout the 52 week treatment period. Participants who had a DBP reading that was >= 10 mm Hg higher than their baseline DBP for any assessment performed during the treatment period were recorded.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    202
    101
    Units: Percentage of Participants
        number (not applicable)
    22.8
    36.6
    Statistical analysis title
    		 Difference in Percentages Between Group
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.011
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -13.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25
         upper limit
    		 -3.1

    Primary: Percentage of Participants With Sodium Levels > Upper limit of normal (ULN)

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    End point title
    		 Percentage of Participants With Sodium Levels > Upper limit of normal (ULN)
    End point description
    Participants had sodium levels assessed throughout the 52 week treatment period. Participants who had any sodium level that was > the ULN of 145 mEq/L were recorded.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    202
    101
    Units: Percentage of Participants
        number (not applicable)
    11.4
    9.9
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.696
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 8.4

    Primary: Percentage of Participants With Chloride Levels > ULN

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    End point title
    		 Percentage of Participants With Chloride Levels > ULN
    End point description
    Participants had chloride levels assessed throughout the 52 week treatment period. Participants who had any chloride level that was > the ULN of 110 mEq/L were recorded.
    End point type
    Primary
    End point timeframe
    up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    202
    101
    Units: Percentage of Participants
        number (not applicable)
    0.5
    0
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.48
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 2.8

    Primary: Percentage of Participants With Potassium Levels < Lower limit of normal (LLN)

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    End point title
    		 Percentage of Participants With Potassium Levels < Lower limit of normal (LLN)
    End point description
    Participants had potassium levels assessed throughout the 52 week treatment period. Participants who had any potassium level that was < the LLN of 3.5 mEq/L were recorded.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    202
    101
    Units: Perentage of Participants
        number (not applicable)
    1.5
    1
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.722
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 3.5

    Primary: Percentage of Participants With Bicarbonate Levels > ULN

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    End point title
    		 Percentage of Participants With Bicarbonate Levels > ULN
    End point description
    Participants had bicarbonate levels assessed throughout the 52 week treatment period. Participants who had any bicarbonate level that was > the ULN of 33 mEq/L were recorded.
    End point type
    Primary
    End point timeframe
    up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    202
    101
    Units: Percentage of Participants
        number (not applicable)
    0
    0
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.999
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 1.9

    Primary: Percentage of (Participants With Consecutive Elevations in Alanine Aminotransferase ALT) and/or Aspartate Aminotransferase (AST) of >=3 x ULN

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    End point title
    		 Percentage of (Participants With Consecutive Elevations in Alanine Aminotransferase ALT) and/or Aspartate Aminotransferase (AST) of >=3 x ULN
    End point description
    Participants had AST and ALT levels assessed throughout the 52 week treatment period. Participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    202
    101
    Units: Percentage of Participants
        number (not applicable)
    1.5
    1
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.722
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 3.5

    Primary: Percentage of Participants With Creatine Kinase (CK) >=10 x ULN

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    End point title
    		 Percentage of Participants With Creatine Kinase (CK) >=10 x ULN
    End point description
    Participants had CK assessed throughout the 52 week treatment period. Participants who had any CK level that was >=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    202
    101
    Units: Percentage of Participants
        number (not applicable)
    0
    1
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.157
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4
         upper limit
    		 0.9

    Primary: Percentage of Participants With CK >=10 x ULN With Muscle Spasms

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    End point title
    		 Percentage of Participants With CK >=10 x ULN With Muscle Spasms
    End point description
    Participants had CK assessed throughout the 52 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle spasms were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    202
    101
    Units: Percentage of Participants
        number (not applicable)
    0
    1
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.157
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4
         upper limit
    		 0.9

    Primary: Percentage of Participants Adjudicated Cardiovascular (CV) SAE

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    End point title
    		 Percentage of Participants Adjudicated Cardiovascular (CV) SAE
    End point description
    An AE or suspected adverse reaction is was considered an SAE if it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. All events were adjudicated by an expert committee independent of the Sponsor. Participants that experienced adjudicated SAEs of CV death, Non-fatal stroke, non-fatal myocardial infarction, or unstable angina were recorded.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    203
    102
    Units: Percentage of Participants
        number (not applicable)
    1.5
    0
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.218
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 4.3

    Primary: Percentage of Participants Who Died From Any Cause - Treatment Period

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    End point title
    		 Percentage of Participants Who Died From Any Cause - Treatment Period
    End point description
    Participants who died from any cause were recorded. All deaths were adjudicated by an expert committee independent of the Sponsor.
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Anacetrapib 100 mg - Safety Population Placebo - Safety Population
    Number of subjects analysed
    203
    102
    Units: Percentage of Participants
        number (not applicable)
    0
    0
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg - Safety Population v Placebo - Safety Population
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.999
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 1.9

    Secondary: Percent Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C)

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    End point title
    		 Percent Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C)
    End point description
    HDL-C levels measured at baseline and after 52 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    173
    88
    Units: Percentage Change
        least squares mean (confidence interval 95%)
    105.8 (101.1 to 110.6)
    3.7 (-2.8 to 10.3)
    Statistical analysis title
    		 Difference in Least Squares Mean Changes
    Statistical analysis description
    Between group comparison of percent change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who receive at least 1 dose of study treatment and have baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    102.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 94.2
         upper limit
    		 110.1

    Secondary: Percent Change From Baseline in non- HDL-C

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    End point title
    		 Percent Change From Baseline in non- HDL-C
    End point description
    Non-HDL-C levels measured at baseline and after 52 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    173
    88
    Units: Percentage Change
        least squares mean (confidence interval 95%)
    -32 (-35.1 to -28.9)
    4.4 (0.1 to 8.8)
    Statistical analysis title
    		 Difference in Least Squares Mean Change
    Statistical analysis description
    Between group comparison of percent change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who receive at least 1 dose of study treatment and have baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -36.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -41.7
         upper limit
    		 -31.1

    Secondary: Percent Change From Baseline in Apolipoprotein B (Apo B)

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    End point title
    		 Percent Change From Baseline in Apolipoprotein B (Apo B)
    End point description
    Apo B levels measured at baseline and after 52 weeks of treatment
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    173
    88
    Units: Percentage Change
        least squares mean (confidence interval 95%)
    -19.6 (-22.5 to -16.8)
    5.2 (1.3 to 9.1)
    Statistical analysis title
    		 Difference in Least Squares Mean Change
    Statistical analysis description
    Between group comparison of percent change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who receive at least 1 dose of study treatment and have baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -24.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.5
         upper limit
    		 -20.1

    Secondary: Percent Change From Baseline in Apolipoprotein A1 (Apo-A1)

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    End point title
    		 Percent Change From Baseline in Apolipoprotein A1 (Apo-A1)
    End point description
    Apo A-1 levels measured at baseline and after 52 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    173
    88
    Units: Percentage Change
        least squares mean (confidence interval 95%)
    35.8 (33 to 38.6)
    2.9 (-1 to 6.8)
    Statistical analysis title
    		 Difference in Least Squares Mean Change
    Statistical analysis description
    Between group comparison of percent change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who receive at least 1 dose of study treatment and have baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    32.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28.2
         upper limit
    		 37.6

    Secondary: Percent Change From Baseline in Lipoprotein(a) (Lp[a])

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    End point title
    		 Percent Change From Baseline in Lipoprotein(a) (Lp[a])
    End point description
    Lp(a) levels measured at baseline and after 52 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    174
    88
    Units: Percentage Change
        median (confidence interval 95%)
    -31.8 (-37.4 to -26.3)
    0 (-5.1 to 5.1)
    Statistical analysis title
    		 Difference in Median Change
    Statistical analysis description
    Between group comparison of percent change from baseline performed using Hodges-Lehmann estimate of the median difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test. Analysis population defined as participants who receive at least 1 dose of study treatment and have baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon's rank sum test
    Parameter type
    		 Median difference (final values)
    Point estimate
    -27.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.7
         upper limit
    		 -21.2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 64 weeks
    Adverse event reporting additional description
    Safety Population included all participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    MK-0859 100 mg (52-week Treatment Phase)
    Reporting group description
    		 one tablet of anacetrapib 100 mg once daily with a meal for 52 weeks

    Reporting group title
    Placebo (52-week Treatment Phase)
    Reporting group description
    		 one tablet of placebo for anacetrapib 100 mg once daily with a meal for 52 weeks

    Reporting group title
    MK-0859 100 mg (12-week Reversal Phase)
    Reporting group description
    		 Completers and non-completers who were administered anacetrapib in treatment period and entered reversal period.

    Reporting group title
    Placebo (12-week Reversal Phase)
    Reporting group description
    		 Completers and non-completers who were administered placebo in treatment period and entered reversal period.

    Serious adverse events
    		 MK-0859 100 mg (52-week Treatment Phase) Placebo (52-week Treatment Phase) MK-0859 100 mg (12-week Reversal Phase) Placebo (12-week Reversal Phase)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 203 (8.87%)
    10 / 102 (9.80%)
    3 / 196 (1.53%)
    2 / 95 (2.11%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 102 (0.98%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 102 (0.98%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 102 (0.98%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Device malfunction
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug resistance
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical device discomfort
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterovaginal prolapse
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Emotional distress
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 102 (0.98%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Gastrointestinal anastomotic leak
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 102 (0.98%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 102 (0.00%)
    1 / 196 (0.51%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 102 (0.00%)
    1 / 196 (0.51%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 102 (0.00%)
    1 / 196 (0.51%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    4 / 203 (1.97%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 102 (0.98%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 102 (0.98%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 102 (0.98%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 102 (0.98%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 102 (0.98%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine with aura
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    1 / 196 (0.51%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Endocarditis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 102 (0.98%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 102 (0.00%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 102 (0.98%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MK-0859 100 mg (52-week Treatment Phase) Placebo (52-week Treatment Phase) MK-0859 100 mg (12-week Reversal Phase) Placebo (12-week Reversal Phase)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    87 / 203 (42.86%)
    41 / 102 (40.20%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 203 (7.88%)
    6 / 102 (5.88%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    19
    7
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    16 / 203 (7.88%)
    9 / 102 (8.82%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    19
    10
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    12 / 203 (5.91%)
    2 / 102 (1.96%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    15
    2
    0
    0
    Myalgia
         subjects affected / exposed
    18 / 203 (8.87%)
    4 / 102 (3.92%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    26
    5
    0
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 203 (0.99%)
    6 / 102 (5.88%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    2
    7
    0
    0
    Influenza
         subjects affected / exposed
    20 / 203 (9.85%)
    11 / 102 (10.78%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    22
    11
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    40 / 203 (19.70%)
    19 / 102 (18.63%)
    0 / 196 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    50
    21
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 May 2012
    AM1: changed the LDL-C method for the primary efficacy endpoint from direct method to beta quantification method and for women of child- bearing potential to report pregnancy anytime during the 2 year time period after stopping study medication.
    01 Nov 2013
    AM2: updated the contraception guidance to women of child- bearing potential and to implement pregnancy follow-up on an annual basis for up to 4 years after the last dose of study medication.
    19 Feb 2015
    AM3: Updated the annual pregnancy follow-up period for women of child-bearing potential (WOCBP) from 4 years to 5 years after the last dose of anacetrapib. Also contraception guidance for WOCBP was extended from 4 to 5 years after last dose of anacetrapib.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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